WO2001097696A1 - Systeme et methode de traitement exovasculaire peu invasif d'un anevrisme - Google Patents

Systeme et methode de traitement exovasculaire peu invasif d'un anevrisme Download PDF

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Publication number
WO2001097696A1
WO2001097696A1 PCT/US2001/019629 US0119629W WO0197696A1 WO 2001097696 A1 WO2001097696 A1 WO 2001097696A1 US 0119629 W US0119629 W US 0119629W WO 0197696 A1 WO0197696 A1 WO 0197696A1
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WIPO (PCT)
Prior art keywords
aneurysm
probe
treatment device
clip
distal end
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PCT/US2001/019629
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English (en)
Inventor
Rudy A. Mazzocchi
Thomas I. Miller
Kari Parmer
Timothy Alan Parmer
Matthew S. Solar
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Image-Guided Neurologics, Inc.
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Application filed by Image-Guided Neurologics, Inc. filed Critical Image-Guided Neurologics, Inc.
Priority to AU2001268587A priority Critical patent/AU2001268587A1/en
Publication of WO2001097696A1 publication Critical patent/WO2001097696A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/128—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips
    • A61B17/1285—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/122—Clamps or clips, e.g. for the umbilical cord
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1482—Probes or electrodes therefor having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37—Surgical systems with images on a monitor during operation
    • A61B2090/374—NMR or MRI
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/10—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis
    • A61B90/11—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis with guides for needles or instruments, e.g. arcuate slides or ball joints
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/50—Supports for surgical instruments, e.g. articulated arms

Definitions

  • TECHNICAL FIELD This document relates generally to minimally-invasive surgical systems, devices, and methods, and particularly, but not by way of limitation, to a system and method of minimally-invasive exo vascular aneurysm treatment.
  • An aneurysm is an abnormal dilatation of a blood vessel. Brain aneurysms pose a particular risk of rupture and resulting hemorrhage, resulting in possible significant loss of brain function and even death. Autopsy studies have estimated that between about 1.5% and 8% of the population have intracranial aneurysms. Between 60,000 and 80,000 cerebral aneurysms are diagnosed annually in the U.S. Of these patients, about 20,000 to 30,000 are diagnosed following the occurrence of subarachnoid hemorrhage. The annual risk of an aneurysmal rupture is about 2%. Patients that experience aneurysmal rupture typically experience a mortality rate of about 50-60%.
  • One conventional technique for treating a brain aneurysm uses standard open surgical intervention techniques. A craniotomy is performed to create a relatively large opening in the patient's skull. The surgeon uses conventional surgical instruments to retract intervening brain tissue to expose the blood vessel at the aneurysm for direct visualization. With the aneurysm and associated blood vessel in view, the surgeon manipulates and treats the aneurysm using traditional surgical instruments to clip or staple either the body of the vessel or the neck of the aneurysm.
  • a catheter may be introduced (e.g., near a subject's groin) through a blood vessel and advanced to the aneurysm.
  • a detachable coil is introduced through the endovascular catheter and "packed" into the interior of the aneurysm.
  • This coil which is usually constructed of stainless steel and/or platinum wire, is intended to interrupt the turbulent blood flow into the aneurysm.
  • the resulting blood clots within the interior of the aneurysm. This reduces the risk of aneurysmal rupture.
  • Another endovascular method of treating aneurysms uses a detachable balloon. The balloon is inflated with cyanoacrylates to occlude the interior of the aneurysm.
  • Yet another endovascular method of treating aneurysms introduces an intravascular stent or graft that occludes the adjacent neck of an aneurysm sufficiently to interrupt blood flow into the aneurysm while maintaining continued flow through the native vessel.
  • endovascular techniques for treating aneurysms have not exhibited as high a likelihood of success as the open surgery techniques discussed above.
  • application of the endovascular techniques is generally limited to non-bifurcating, small-neck aneurysms, which actually constitute a small percentage of the clinically-diagnosed aneurysms.
  • some aneurysms are exceedingly difficult to reach endovascularly because they require traversal of a long tortuous path through the accessing vessels.
  • the present inventors have recognized a need for improved techniques and associated devices for accessing and treating brain or other aneurysms.
  • this document discusses a minimally-invasive exovascular approach to treating an aneurysm.
  • the surgeon need only make a small opening for inserting an exovascular instrument to the aneurysm.
  • the surgeon need not visualize the aneurysm directly.
  • a magnetic resonance imaging (MRI), computed tomography (CT), or other suitable imaging device is provided to allow the surgeon to exovascularly guide a minimally-invasive aneurysm treatment device through the brain to the aneurysm, apply the treatment device to the desired portion of the aneurysm, and then remove the aneurysm treatment device.
  • an image-guided entry device is used to provide more accurate targeting and determination of a trajectory from the minimally-invasive entry opening to the aneurysm to be treated.
  • the minimally-invasive techniques discussed in this document may permit more effective treatment of aneurysms that would be difficult to access or treat using endovascular techniques. Moreover, these minimally-invasive techniques may result in less shifting of brain tissue than open surgery techniques. This may permit more accurate targeting of the aneurysm, and less trauma to the intervening brain tissue.
  • this document discusses a system that includes an elongate exovascular probe.
  • the probe includes proximal and distal ends.
  • the probe also includes an outer dimension that is less than about 18 millimeters to permit the probe to be introduced through a similarly-sized minimally-invasive opening in a portion of a subject's skull and exovascularly advanced to an aneurysm within the skull.
  • the system also includes an aneurysm treatment device carried by the probe.
  • the aneurysm treatment device is dimensioned to permit the aneurysm treatment device to be introduced through the opening, hi another example, this document discusses a method of aneurysm treatment. The method includes forming an opening in a subject's skull.
  • the opening having a diameter that is less than or equal to the diameter of a burr hole.
  • a probe is exovascularly inserted through the opening to an aneurysm using real-time or preoperative imaging to guide the probe to the aneurysm.
  • An aneurysm treatment device is exovascularly introduced through a lumen in the probe to the aneurysm. Using the aneurysm treatment device, a morphology of the aneurysm is altered.
  • Figure 1 is a schematic/block diagram illustrating generally an example of portions of a minimally-invasive aneurysm treatment system and portions of an environment in which it is used.
  • Figure 2 is a schematic/block diagram of another example of portions of an aneurysm treatment system, in which a distal tip of a catheter also includes a local imaging device for providing enhanced visualization of nearby regions, such as an aneurysm and nearby blood vessels and brain tissue or other structures.
  • Figure 3 is a schematic/block diagram of a further example of portions of an aneurysm treatment system, further including an entry device located at, in, and/or around an entry opening.
  • Figure 4 is a cross-sectional schematic diagram illustrating generally an example of a distal end of a catheter. Disposed in a retracted position within a lumen of the catheter is distal end of an example aneurysm treatment device.
  • Figure 5 includes several cross-sectional diagrams illustrating generally one technique for operating the aneurysm treatment device of Figure 4.
  • Figure 6 is a schematic illustration of several alternative components for aneurysm-clipping in an aneurysm treatment device.
  • Figure 7 is a cross-sectional schematic diagram illustrating generally another example of a distal end of a catheter, the distal end including a lumen through which another example aneurysm treatment device is disposed for treating an aneurysm.
  • Figure 8 includes several cross-sectional diagrams illustrating another example of a distal portion of a snare-like aneurysm treatment device that includes a strand, the end of which has a normally-looped shape-memory property.
  • Figure 9 is a perspective view illustrating another example, of an aneurysm treatment device, which includes a pair of electrodes that are exovascularly delivered through a lumen of a catheter.
  • Figure 10 is a perspective view illustrating another example of an aneurysm treatment device including a movable electrode and a fixed electrode.
  • Figure 11 is a perspective view illustrating another example of a catheter- delivered aneurysm treatment device, which in this case includes a C-channel clamp shaped for being fitted around an exterior portion of a blood vessel and clamping a desired portion of an aneurysm therebetween.
  • Figure 12 is a perspective view illustrating a number of possible variations of the minimally-invasive aneurysm treatment techniques discussed above, such as nasalpharyngeal access, frame-mounted entry devices, using a plurality of minimally-invasive devices, and/or using separate minimally- invasive devices for imaging and aneurysm treatment.
  • FIG. 1 is a schematic/block diagram illustrating generally an example of portions of a minimally-invasive aneurysm treatment system 100 and portions of an environment in which it is used. In this example, a portion of a top or side of a patient's skull 100 and scalp 102 are illustrated. A minimally-invasive entry opening 104 is created through skull 100 and scalp 102.
  • opening 104 is a substantially circular burr-hole having a diameter that is approximately between 8 millimeters and 18 millimeters, such as about 14 millimeters.
  • a exovascular probe/tube/catheter 106 (or other rigid, semi-rigid, or flexible device) is inserted through opening 104, and is directed toward an aneurysm (e.g., a saccular, globular, giant, or other aneurysm) 108 associated with blood vessel 110 within brain 112.
  • Catheter 106 includes a lumen 114 extending between its proximal end 116 and its distal end 118.
  • catheter 106 has an outer diameter that is less than the burr-hole diameter.
  • catheter 106 has an outer diameter that is less than about 10 millimeters, such as an outer diameter of about 5 millimeters. In general, using a smaller outer diameter value results in less trauma to the intervening tissue. In one example, catheter 106 has an inner (i.e., lumen) diameter that is approximately between 1 millimeter and 8 millimeters, such as about 3 millimeters.
  • An aneurysm treatment device 120 is inserted through lumen 114 in catheter 106.
  • Aneurysm treatment device 120 includes a proximal end 122 and a distal end 124.
  • Distal end 124 of aneurysm treatment device 120 includes a device for altering a morphology of aneurysm 108, such as to reduce the risk of its rupture.
  • Such aneurysm treatments include, by way of example, but not by way of limitation, clipping, clasping, snaring, looping, hooking, stapling, applying electrical energy to diathermically heat and/or electrocauterize, grasping, retrieving, securing, and/or aspirating the contents of an aneurysm.
  • the devices for performing such treatments may be mechanical, chemical and/or electromagnetic. The choice of an appropriate treatment will depend on the size, location, and type of aneurysm.
  • imaging device 126 is a magnetic resonance (MR) imaging device and/or a computed tomography (CT) imaging device providing real-time and/or preoperative images for guiding catheter to aneurysm 108 and then treating aneurysm 108.
  • MR magnetic resonance
  • CT computed tomography
  • imaging modalities allow the surgeon to view images that include information about the three dimensional morphology of the aneurysm, the vessel associated with the aneurysm, and any nearby major and perforating vessels in and around the base of the aneurysm.
  • the information yielded by such imaging modalities is advantageous for deciding whether and how to proceed with the aneurysm treatment, or for selecting a particular device
  • an MR or CT imagable fiducial structure is positioned at a predetermined location at one or both of distal end 118 of catheter 106 and/or a distal end 124 of aneurysm treatment device 120 to create a locatable image for guiding and operating that particular device.
  • the fiducial structure may produce either a positive image on the imaging modality or, alternatively, may be recognizable by producing a contrast with the image of the surrounding brain tissue.
  • Figure 2 is a schematic/block diagram of another example of portions of aneurysm treatment system 100 in which distal tip 118 of catheter 106 also includes a local imaging device 200 for providing enhanced visualization of nearby regions, such as aneurysm 108 and nearby blood vessels and brain tissue or other structures.
  • local imaging device 200 includes at least one microcoil for local MR imaging.
  • Patent Application No. 09/532,145 filed on March 21, 2000, entitled “A DEVICE FOR HIGH GAIN AND UNIFORMLY LOCALIZED MAGNETIC RESONANCE IMAGING;” Viswanathan U.S. Patent Application No. 09/532,667, filed on March 21, 2000, entitled “A MICROCOIL DEVICE FOR LOCAL, WIDE FIELD-OF-VIEW AND LARGE GAIN MAGNETIC RESONANCE IMAGING;” and Viswanathan U.S. Patent Application No.
  • one or more of such microcoils is molded into distal end 118 of catheter 106, with appropriate connection wires extending along the length of elongate catheter 106 to its proximal end 116 for coupling to imaging device 126 or other suitable device for delivering and/or receiving energy for performing the local imaging.
  • Such microcoils typically enhance the visual resolution of the imaging at the working distal end 118 of catheter 106 or other probe.
  • This actively- visible deployment probe improves the surgeon's ability to visualize the overall structure and position of the aneurysm as well as any branching capillaries or perforators that might be extending from the aneurysm or its vicinity. This can be important in ensuring effective treatment of the aneurysm.
  • localized imaging allows the surgeon to avoid damaging such ancillary vessels, thereby preserving needed blood flow through such vessels to surrounding tissue. Alternatively, it allows the surgeon to also provide similar or different treatment to such ancillary vessels, where appropriate.
  • imaging of ancillary vessels permits the surgeon to cauterize one or more of such vessels to avoid possible hemorrhaging and/or related complications.
  • Figure 3 is a schematic/block diagram of a further example of portions of system 100 further including an entry device 300 located at, in, and/or around minimally-invasive entry opening 104.
  • ball-and-socket-type entry device 300 includes a stem-like cylindrical trajectory guide 302 that is used in conjunction with imaging device 126 to determine and lock-in a desired trajectory from opening 104 to aneurysm 108.
  • Suitable examples of skull- mounted entry device 300, and ancillary devices and techniques for introducing a medical instrument such as catheter 106, are described in: Truwit et al. U.S. Patent No.
  • FIG. 4 is a cross-sectional schematic diagram illustrating generally an example of distal end 118 of catheter 106. Disposed in a retracted position within lumen 114 of catheter 106 is distal end 124 of an example aneurysm treatment device 120.
  • aneurysm treatment device 120 includes a clip 400, an O-shaped ring 402 (or C-shaped partial ring), a wire-like retaining strand 404 snaring clip 400 (or other retention device), a middle tube 406 having a lumen 408 therethrough, and an inner tube 405 also having a lumen therethrough through which a portion of strand 404 extends.
  • clip 400 is a molded plastic clip having a normally-open shape-memory property. When it is pushed out of lumen 114, such as by inner tube 405, jaws 410A-B of clip 400 spring open apart from each other such that clip 400 is in a substantially open position.
  • Jaws 410A-B are then positioned around a desired portion of aneurysm 108 (such as around a neck portion at which aneurysm 108 extends from vessel 110, but leaving enough tissue to bridge the gap in the wall of the vessel created by the aneurysm). Then, jaws 410A-B are closed around the desired portion of aneurysm 108. In one example, this is accomplished by firmly holding retaining strand 404, which is looped around a knob 412 or within a groove 414 of clip 400, while pushing middle tube 406 out from lumen 114. In this manner, middle tube 406 engages ring 402 and pushes ring 402 out around jaws 410A-B.
  • inner tube 405 is optionally withdrawn to promote loosening and disengaging retaining strand 404 from clip 400. Retaining strand 404, middle tube 406, inner tube 405, and catheter 106 are then withdrawn from brain 112, and minimally-invasive opening 104 is closed.
  • Figure 5 includes several cross-sectional diagrams illustrating generally one technique for operating this example of aneurysm treatment device 120 of Figure 4.
  • retaining strand 404 includes a third strand extending through lumen 114 and coupled to a collar around the illustrated looped pair of strands of retaining strand 404. By tightening or loosening the collar by manipulating the third strand, the loop is more securely opened or closed to respectively release or retain clip 400.
  • retaining strand 404 (which need not be a loop, but is alternatively a single strand affixed to a portion of clip 400), includes a pre-weakened breakaway portion at or near clip 400.
  • distal end 118 of catheter 106 includes an inward extending longitudinal slot that is shaped to permit one of jaws 410A-B to spring outward toward its substantially open position even before clip 400 is extended out of lumen 114. This permits clip 400 to open around aneurysm 108 along the side of catheter 106 rather than concentrically outward.
  • FIG. 6 is a schematic illustration of several alternative components for aneurysm-clipping in an aneurysm treatment device.
  • clip 600 includes distal hook 602 or other self-locking mechanism that avoids the need for a separate sliding ring 402 to close and/or retain clip 600 in its substantially closed position.
  • clip 600 has a normally-open shape-memory property.
  • Clip 600 may be delivered through catheter 106 and closed by a middle tube 406 or any other suitable technique.
  • Clip 604 includes another example of a self-locking mechanism, such as a ring 606 located at a distal end of one of its jaws.
  • This self-locking mechanism moves (e.g., rotates) to engage the distal end of the opposing jaw to retain normally-open clip 604 in its substantially-closed position.
  • Clip 604 may also be delivered through catheter 106 and closed by a middle tube 406 or other suitable technique.
  • Clip 608 is an example of a geared latch hook device that is delivered through catheter 106 and closed around a portion of aneurysm 108.
  • clip 608 includes a body portion 610 and a hook portion 612. It also includes a resilient strand 614 or shaft that extends to proximal end 116 of catheter 106. By pushing on a proximal end of strand 614, curved hook portion 612 is closed around aneurysm 108. A distal portion of curved hook portion is received by hole 616 in clip body 610.
  • One or more teeth 618 on hook 612 engages a pawl-like device associated with hole 616, allowing hook 612 to clasp and retain aneurysm 108.
  • Body 610 and strand 614 are releasably coupled to hook 612 by any suitable releasable fastening technique.
  • suitable examples include, by way of example, but not by way of limitation, a pre- weakened breakaway portion, a rotatably-releasable strand or shaft, and/or a threaded coupler.
  • Clip 620 is an example of another aneurysm clip or clasp that is delivered through catheter 106 and closed around aneurysm 108.
  • clip 620 includes a body 622 portion and a hooked shaft 624 portion that operate together in a padlock-like fashion to clasp and retain aneurysm 108.
  • Strand or shaft 626 engages hooked shaft 624 to pull it back, thereby clasping the desired portion of aneurysm 108 between hooked shaft 624 and body 622 of clip 620.
  • Strand 626 releasably engages hooked shaft 624, such as by one of the above-described releasable fastening techniques, or by simply receiving a hooked or other suitably shaped portion of a distal end of strand 626 in a slot or other suitable opening from which it can be disengaged by manipulating the proximal end of strand 626.
  • Clip 628 is an example of yet another aneurysm clip or clasp that is delivered through catheter 106 and closed around aneurysm 108.
  • clip 628 is a double bow-like clasp having a normally-closed shape- memory property. After being delivered through catheter 106, tension is applied to force its midregions outward so that aneurysm 108 can be positioned therebetween.
  • One technique for applying such tension is to use one or more resilient strands or shafts that releasably engage features on clip 628 (e.g., receptacles 630A-B).
  • clip 628 includes a normally- open shape-memory property.
  • Such a normally-open clip 628 is closed around aneurysm 108 using a suitable closure technique, such as by using a middle tube 406 to push a surrounding ring 402 out around normally open clip 628 to close it around aneurysm 108.
  • FIG. 7 is a cross-sectional schematic diagram illustrating generally another example of distal end 118 of catheter 106, the distal end 118 including a lumen 114 through which another example aneurysm treatment device 120 is disposed for treating aneurysm 108.
  • aneurysm treatment device 120 includes a wire-like snare 700 having at least one strand that extends through lumen 114 of catheter 106 from its proximal end 116 to its distal end 118, and extending outward from distal end 118 in a loop 702. In its substantially open position, as illustrated in Figure 7, loop 702 is large enough to encircle a desired portion of aneurysm 108.
  • snare 700 extends through a unidirectional retention mechanism, such as cuff 704, in lumen 114 at distal end 118 of catheter 106.
  • cuff 704 includes two pieces 704A-B that lock when snare 700 is rotated after loop 702 is pulled snugly around aneurysm 108 to tie off aneurysm 108.
  • snare 700 includes a pre-weakened breakaway portion that is slightly more proximal than cuff 704, so that when the user pulls firmly back on the proximal end of snare 700 with sufficient tension, snare 700 breaks away to leave behind loop 702, around aneurysm 108, and securing cuff 704.
  • aneurysm treatment device 120 also includes a middle tube 406 having a lumen 408 through which a portion of snare 700 extends.
  • the user pushes on the proximal end of middle tube 406 to push against cuff 704, while the proximal end of snare 700 is being pulled back, to break the pre-weakened portion of snare 700. Then, the user further pushes on the proximal end of middle tube 406 to push out and release cuff 704 and the tightened loop portion of snare 700.
  • cuff 704 includes a blade-like projection that cuts a portion of snare 700 to release loop 702 after it is secured around aneurysm 108.
  • other modes of unidirectional retention devices operating noose-like loops 702 include a toothed or other structure operating similarly to a plastic cable-tie and/or a bag- tie, or a pawl or other ratcheting/escapement mechanism that allows loop 702 to be securely tightened around aneurysm 108.
  • Figure 8 includes several cross-sectional diagrams illustrating another example of a distal portion of a snare-like aneurysm treatment device 120 that includes a strand 800, the end of which has a normally-looped shape-memory property.
  • strand 800 extends from proximal end 116 to distal end 118 of catheter 106 through its lumen 114, through a central lumen of a middle tube 406, and through a central lumen of ring 402.
  • a distal end of strand 800 is extended out from the distal end 118 of catheter 106 for a sufficient distance to allow its shape-memory property to hook the distal end of strand 800 around the desired portion of aneurysm 108.
  • the distal end of strand 800 includes a catch 802 (e.g., a ball, a grooved ball, a hook , or any other suitable structure).
  • Catch 802 engages a more proximal portion of strand 800 after being hooked around the desired portion of aneurysm 108.
  • Middle tube 406 is then used to push ring 402 out over catch 402. Then, the proximal end of strand 800 is pulled back to draw a noose-like loop to clamp off the desired portion of aneurysm 108.
  • strand 800 includes a more proximal pre-weakened portion that breaks away when sufficient tension is applied, leaving behind the loop and ring tying off aneurysm 108.
  • a portion of strand 800 includes a toothed or other structure operating similarly to a plastic cable-tie and/or a bag-tie, or a pawl or other ratcheting/escapement mechanism, as ' discussed above, to retain the now-looped hook snare in its substantially closed position around aneurysm 108.
  • ring 402 is omitted, and catch 802 includes a hook or other suitable structure that catches a more proximal portion of strand 800 when its proximal end is drawn back to break away a pre-weakened portion of strand 800 that is more proximal than the engaged hook.
  • FIG. 9 is a perspective view illustrating another example of an aneurysm treatment device 900.
  • aneurysm treatment device 900 includes a pair of electrodes 902A-B that are exovascularly delivered through lumen 114 of catheter 106.
  • electrodes 902A-B are elongate paddles extending outward from respective insulated stylet shafts 904A-B at resiliently flexible outward necked portions 906A-B. In this manner, when electrodes 902A-B are extended out of lumen 114 at distal end 118 of catheter 106, they spring outward into a substantially open position to allow aneurysm 108 to be positioned therebetween.
  • FIG. 10 is a perspective view illustrating another example of an aneurysm treatment device 1000 including a movable electrode and a fixed electrode.
  • aneurysm treatment device 1000 includes a movable electrode 1002 extending out from lumen 114 at distal end 118 of catheter 106 on an electrically insulated stylet shaft 1004.
  • a flat fixed electrode 1006 is formed integrally with distal end 118 of catheter 106, extending outwardly therefrom, with an associated conductor coupling it to proximal end 116 of catheter 106.
  • fixed electrode 1006 is first positioned adjacent to aneurysm 108. Then, movable electrode 1002 is extended out around the other side of aneurysm 108.
  • movable electrode 1002 includes a rolling electrode that is rolled back and/or forth along aneurysm 108, by manipulating a proximal end of shaft 1004, to clamp the desired portion of aneurysm 108 between the electrodes 1002 and 1006 as electrical energy is applied to cauterize shut the desired portion aneurysm 108.
  • FIG 11 is a perspective view illustrating another example of a catheter- delivered aneurysm treatment device, which in this case includes a C-channel clamp 1100 shaped for being fitted around a portion of blood vessel 110 and clamping a desired portion of aneurysm 108 therebetween.
  • C- channel clamp 1100 is mounted on the tip of a stylet shaft having a sufficient diameter to keep channel 1102 sufficiently open to slide around the desired portion of aneurysm 108 when the stylet shaft is extended out of distal tip 118 of catheter 106.
  • a second stylet (or a middle tube, such as middle tube 406) is used to slide C-channel clamp 1100 off the first stylet into place around vessel 110 and aneurysm 108.
  • C-channel clamp 1100 has a normally- closed shape-memory property, so that it closes around the desired portion of aneurysm 108 after it is slid into place off of the first stylet shaft.
  • electrically insulative C-channel clamp 1100 also includes conductive electrodes 1104A-B located along the edges of its C-channel for cauterizing closed the clamped portion of aneurysm 108.
  • electrodes 1104A- B include receptacles, at any suitable location, for subsequent access by conductors delivering the electrical cautery energy after the delivery stylet(s) are removed from lumen 114 of catheter 106.
  • Figure 12 is a perspective view illustrating a number of possible variations of the minimally-invasive aneurysm treatment techniques discussed above, such as nasalpharyngeal access, frame-mounted entry devices, using a plurality of minimally-invasive devices, and/or using separate minimally- invasive devices for imaging and aneurysm treatment.
  • minimally-invasive aneurysm treatment techniques discussed above, such as nasalpharyngeal access, frame-mounted entry devices, using a plurality of minimally-invasive devices, and/or using separate minimally- invasive devices for imaging and aneurysm treatment.
  • Figure 3 illustrated access through the top or the side of a patient's skull
  • Figure 12 illustrates a nasalpharyngeal node of access through a patient's nose and sinuses.
  • a rotatable arc-like frame 1200 is mounted to a head holding device 1202.
  • a first entry device e.g., entry device 1204A
  • a second entry device e.g., entry device 1204B
  • a minimally-invasive localized imaging modality e.g., a microcoil for localized MRI, an endoscope for optical visualization, and ultrasound probe, etc.
  • example materials suitable for constructing catheter 106, middle tube 406, inner tube 405, and/or cuff 704 include, by way of example, but not by way of limitation, one or a combination of nonmagnetic carbon fiber, titanium, rigid or semi-rigid extruded plastic, polyetheretherketone (PEEK), and/or polyurethane.
  • PEEK polyetheretherketone
  • polyurethane In a non-MR (e.g., CT) environment, in which nonmagnetic components are not required, stainless steel is also an example of a suitable material for these components.
  • Example materials suitable for constructing ring 402, clip 400, clip 600, clip 604, clip 608, clip 620, and/or clip 628 include, by way of example, but not by way of limitation, one or a combination of titanium, polyurethane, polyolefin, polyethylene, and/or polypropylene.
  • suitable materials for constructing strand 404 and/or snare 700 include, by way of example, but not by way of limitation, one or a combination of titanium, tungsten, platinum-iridium, an extruded plastic monofilament, nylon, and/or KEVLAR. ®
  • strand 404 could be constructed from a twisted pair of strands constructed from the same or different ones of these or other materials.
  • suitable materials for constructing hook/snare portion of strand 800 include, by way of example, but not by way of limitation, nickel-titanium (nitonol) and/or other suitable nonmagnetic memory metal.
  • suitable materials for constructing electrodes 902A-B, electrode 1002, electrode 1006, and/or electrodes 1104A-B include, by way of example, but not by way of limitation, one or a combination of platinum-iridium and/or other nonmagnetic conductive material.
  • suitable materials for constructing frame 1200 include, by way of example, but not by way of limitation, one or more of aluminum and/or other rigid nonmagnetic material.

Abstract

L'invention concerne une méthode de traitement exovasculaire d'un anévrisme au moyen d'un instrument peu invasif guidé par imagerie par résonance magnétique (IRM), par tomographie par ordinateur (CT), ou par un autre dispositif d'imagerie adapté. Un dispositif d'entrée de guidage de trajectoire aide à cibler l'anévrisme et à déterminer une trajectoire adaptée pour y accéder. Les dispositifs de traitement d'anévrisme sont, par exemple, une pince, une attache, un collet, une boucle, un crochet, une agrafe, un électrocautère ou autre électrode, ou une quelconque combinaison de ces dispositifs. Le dispositif de traitement d'anévrisme est délivré par une sonde, par exemple un tube ou autre cathéter.
PCT/US2001/019629 2000-06-19 2001-06-19 Systeme et methode de traitement exovasculaire peu invasif d'un anevrisme WO2001097696A1 (fr)

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